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Class Action Against French Manufacturer of Epilepsy Drug

The families of children who were born with developmental defects have formed a class action against the French manufacturers of the epilepsy drug Epilim.

Depakine was introduced into France in the 1960s as an anti-epilepsy drug, and was later introduced in Ireland under the trade name Epilim. The active ingredient of the drug is sodium valproate, and it has also been prescribed to treat bipolar disorder, migraine and other chronic pain conditions because of an agent in valproate called GABA that stabilises electrical activity in the brain.

When taken by woman during pregnancy, the sodium valproate is converted into valproic acid. When this enters the bloodstream, it can have an adverse effect on the health of the unborn child and affect its development. Children born with “foetal valproate syndrome” have been known to suffer from a range of congenital and development issues including autism and spina bifida.

The first signs that there could be risks of foetal valproate syndrome related to taking Epilim during pregnancy were first identified in the 1980s. However, the evidence in these cases was considered not sufficiently conclusive and was allegedly covered up to prevent “fruitless anxiety” by those who used the drug. The French manufacturer of the drug, Sanofi, later informed leading medical bodies of the risks in 2006. In spite of this warning, many medical professionals were left in the dark about the true extent of the drugs effects.

Only recently has France’s National Agency for the Safety of Medicines (ANSM) looked deeper into the birth defect claims against Sanofi. The agency has recently published a report revealing that up to 4,100 children were born between 2007 and 2014 with “severe malformations” due to their mothers having taken the French version of Epilim. Tragically, the report also states that hundreds more are likely to have died in the womb.

In light of the report, the children´s parents sought legal counsel, and now are forming a class action making birth defect claims against Sanofi. The claim is being made on the grounds that the drug manufacturer failed to adequately advise the medical professional of the risks associated with Epilim or print warnings on the outside of the packets. The French government has also got involved and is discussing a compensation package.

In Ireland, Epilim is still sold without a warning on the front of the packet. It is not known how many children have been diagnosed with foetal valproate syndrome due to being exposed to valproic acid in the womb. The Disability Federation in Ireland has called on the government to conduct an audit of children diagnose with foetal valproate syndrome. If a family member has been affected by this issue, and you would like to know more about birth defect claims against Sanofi, please do not hesitate to speak with a solicitor.

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